In fact, the thing to test is whether or not it can be used to facilitate gathering the TIs for a given Standardized Numerical Identifier (SNI) going back to the original manufacturer, as needed after November 27, 2023 during a suspect product investigation or recall. Those are rare events compared with the number of drug sales and shipments where the TI and TS will need to be exchanged.

Governments around the world recognize the problem that the World Health Organization (WHO) once called Substandard/Spurious/ Falsely-labelled/Falsified/ Counterfeit medical products, or SSFFC, but more recently calls Substandard and Falsified medical products. These governments recognize the problem, and their citizens suffer from it, but some of them don’t seem to know what to do about it. Nigeria, Kenya and other countries in Africa have been very assertive in attacking the problems, but other poorer countries without strong central governments can’t afford or don’t have the will necessary to take strong action.

The Drug Quality and Security Act (DQSA) was constructed back in 2013 by Congressional staff, with input from the FDA, members of the industry and who knows who else. There was one bill in the House of Representatives and a different bill in the Senate. Once these bills passed their respective houses, they formed a conference committee who merged the two bills into the final text that we know today as the DQSA (see “It’s Official, President Obama Signs H.R. 3204, DQSA, Into Law”). Chapter 2 of that act is the Drug Supply Chain Security Act (DSCSA). Most readers of RxTrace haven’t forgotten that history but it is important to look back at that history to explain why most companies can ignore certain requirements in the law. That’s right. There are requirements in the law that you can ignore because they will not be enforced by anyone. They are the result of the disjoint way the DQSA was written. Let me explain. Continue reading 3 DSCSA Requirements You Can Totally Ignore→

The Enhanced Drug Distribution Security (EDDS) phase of the Drug Supply Chain Security Act (DSCSA) is due to begin on November 27, 2023. That’s the first day that the US pharma supply chain is supposed to fully operate with serial numbers. Yes, serial numbers in human readable and encoded into 2D barcodes will be on every drug packaged after November of this year, but there is only limited use of those serial numbers in the supply chain until 2023. But when the EDDS starts, everything changes. From that point on, every Transaction Information (TI) document must include the full DSCSA Unique Identifiers—including the serial numbers for the first time—that are physically included in the shipment, the Transaction History (TH) no longer needs to be exchanged, and the data exchange requirements change. Let’s focus in on those data exchange changes. Continue reading EDDS: The New Data Exchange Requirements→

DISCLAIMER: RxTrace contains some of the personal thoughts, ideas and opinions of Dirk Rodgers. The material contained in RxTrace is not legal advice. Dirk Rodgers is not a lawyer.The reader must make their own decisions about the accuracy of the opinions expressed in RxTrace. Readers are encouraged to consult their own legal counseland trading partners before taking any actions based on information found in RxTrace. RxTrace is not a vehicle for communicatingthe positions of any company, organization or individual other than Dirk Rodgers.